Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order

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ClinicalTrials.gov Identifier: NCT00282165

Recruitment Status
:
Terminated
(Required number of subjects to be included could not be accomplished)

In a double blind randomized clinical trial with cross-over design, treatment using naratriptan will be compared to placebo within a group of 30 convicts with psychiatric disorders such as psychosis or psychopathy with repeated aggressive outbursts resistant to conventional psychopharmacologic and other psychotherapeutic treatment. Hypothesis is that addition of naratriptan to the individual treatment regime reduces aggression -and improves general outcome- as compared to addition of placebo and is well tolerated in this group and under these conditions.

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient under psychiatric treatment order for violent crime

More than two violent incidents in the year preceding inclusion, of which at least one within the last three months

Increased risk of coronary vasospasm: symptoms of vascular disorder (including angina pectoris), history of vascular incidents, severe HBP, ECG-abnormalities in history or at screening prior to inclusion, vascular of cardial souffles.

History of vascular incidents, hyperlipidaemia, severe HBP, DM

Use of vasoconstrictive agents such as ergotamine derivates including methysergide, or other triptans.

Increased risk of serotonergic syndrome: use of irreversible MAO-blocker